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Food and Drug Safety: Policy Challenges in a Globalized Era

Subject: Policy Challenges in a Globalized Era

Speakers: Dirceu Barbano, Director, President, National Agency of Sanitary Surveillance, Brazil, Margaret Ann Hamburg, Commissioner, U.S. Food and Drug Administration, and Howard Zucker, Senior Adviser, Division of Global Health and Human Rights, Massachusetts General Hospital, Former Assistant Director-General, World Health Organization
Presider: Susan Dentzer, Editor-In-Chief, Health Affairs
February 2, 2011

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(Mr. Barbano's remarks are provided through interpreter.)

SUSAN DENTZER: Good morning. I'm Susan Dentzer from Health Affairs. I have the honor to be moderating our next panel -- our first panel, having laid out the scope of the issues with respect to drug and food safety. Our second panel is now going to focus on what problems have stood in the way of building what would otherwise be easy and obvious policy prescriptions. Now, "easy and obvious," of course, we will discuss over the course of this next panel, how easy and obvious those are.

Nonetheless, our first panel, I think, set up some of the issues that we will be talking about, those realities, as Commissioner Hamburg said, that make each and every one of us really vulnerable; whether they are weak laws, whether they are under-staffed regulatory agencies, whether it's diffuse authority, whether it's the complexity of the supply chain or what have you, or just the sheer volume.

Peggy Hamburg, I remember several years ago in the thick of the importation debate, going up to see a warehouse that FDA has out at JFK Airport where there were literally tens of thousands of seized packages of medications that had come in from other countries, individually imported by Americans, leaving me aghast at what Americans are willing to put into their bodies for one thing.

But secondly, just with a much fuller appreciation of just the scope of the issues as Laurie (sp) said, many of them being packages from Japan -- excuse me, from China and India, as well as other countries.

So we're going to be discussing what problems have stood in the way of building these easy and obvious policy prescriptions. And so we're delighted to have back with us, once again, Commissioner Hamburg in the center there. Also, just to my right here, Howard Zucker, who was formerly with the World Health Organization as assistant director- general in charge of the so-called health technology and pharmaceuticals cluster and also representative of the director- general on intellectual property, innovation and public health.

He's now senior adviser in the division of global health and human rights at Massachusetts General Hospital.

And we're also very happy to have with us Dirceu Barbano, who has been and is director of the National Agency of Sanitary Surveillance in Brazil since 2008. And also as the director -- chairman of that agency.

So, with that, let's go some further definition of the scope of the problems that are standing in the way of building easy and obvious solutions. And again, in the interests of giving some texture to this issue, I've asked each of our panelists to just frame a quick little case study in their memory that surfaces the complexity of the issues involved.

So, Commissioner Hamburg, let's start with you. What was your favorite experience in this field?

MARGARET HAMBURG: Well -- (laughter) -- I was asked to speak briefly, very briefly about a food safety issue, which actually occurred before my tenure as FDA commissioner, but was something that was very much in the papers and carries implications still, and that had to do with an event that was referenced earlier about salmonella contamination of peppers. And it was a complex challenge, both in relation to the complexity of the supply chain and agricultural practices and conditions across borders and the nature of the food supply.

But it also had to do with the challenges in terms of the underlying science and investigation of food-borne outbreaks. It was an instance where initially -- and others in the room were closer to it, so, you know, I may get the details wrong -- but we'll view it as a symbolic example of cases of food-born illness were reported, was linked to a certain strain of salmonella. It appeared to be linked to tomato products initially and some of the cases, I think, were emerging from Mexican food proprietors where peppers and tomatoes are often served together.

But in any case, it was initially believed to be tomatoes. As Dr. Besser mentioned in the first panel, took quite a toll on the tomato industry as the first warnings went out vis a vis the contamination of tomato products.

It actually emerged with further epidemiological investigation and analysis, FDA working closely with CDC, who takes the lead on the outbreak investigation and epidemiology that there was either cross- contamination between tomatoes and peppers or that it was actually the peppers, not the tomatoes that were the cause and that these were not domestic products, but, in fact, peppers coming in from Mexico, although peppers and tomatoes were, in fact, in Mexico being grown on the same farms as well.

So it was a very confusing picture about what the product was and the origin of the contamination. It was eventually linked back to a much more limited and specific set of circumstances in Mexico, the coordination of Mexican authorities and U.S. authorities to remediate the situation, to get the at-risk product off the market to inform the public all then fell into place.

But it was a prolonged period of trying to determine the source of the foodborne illness, with some missteps that required engagement of domestic food producers and providers as well as counterparts in Mexico. And at the end of the day it took a toll on human health, it took a toll on the economic health of several food industries, and even after the outbreak was actually controlled, persistent concerns about the safety and quality of those products more broadly.

So it does speak to a number of the important issues before us in terms of how can we work together to prevent problems like that from happening in the first place, as well as how can we harness across sectors and components of government to be able to identify and respond to problems as quickly as possible, to try to have seamless coordination across borders, and how to also communicate important information to consumers while they are trying to make choices, and also how to better let consumers know when, in fact, the acute episode has been resolved.

DENTZER: But it sounds like there was, at least initially, a lack of cooperation on the scientific side between Mexican authorities and U.S. authorities, yes? Was that a particular issue?

HAMBURG: You know, I don't think that was the case, but I could be wrong. I wasn't involved at the time. I think it was more complexity of understanding the issues and a failure to cooperate scientifically. There was confusion originally, because the initial outbreak investigation suggested the tomatoes. And I'm sure there was a reluctance to engage initially, where Mexico thought it was somebody else's problem, and now fingers were being pointed to them.

DENTZER: Denial, as they say, not just being a river in Egypt, as the bad joke goes. (Laughter.)

So Howard, in your case, you lived through, on the drug-safety side, a version of the events that were alluded to earlier, in the first panel. Tell us briefly about those, and specifically what obstacles surfaced.

HOWARD ZUCKER: Well, I think that the key issue here that I wanted to raise a little bit was about the impact, which was addressed at the beginning. When I -- when I arrived in Geneva, I literally, without exaggeration, I probably wasn't in my office more than a day and I already received calls from scientists, members from within the WHO as well as individuals in industry and civil-society groups, saying, what are we going to do about counterfeit medicines?

So from that generated the working group within WHO to talk about this, which ultimately crystallized into the International Medical Products Anti-Counterfeiting Task force, or IMPACT, which it's better known as, which I led for the first two years after it was formed.

What we did in that point was to try to bring together individuals from all different groups, whether it was FDA, EMEA, other regulatory agencies around the world.

DENTZER: EMA being the European --

ZUCKER: The European Medical -- yeah -- agency.

Also, OECD, Organization for Economic Cooperation and Development; industry, academia, and public-health experts from around the world -- and brought them together to say, how do we -- how do we tackle this? And from that came five different areas, which some of you might know, which involved everything from regulation, legislation, enforcement, technology and communication, and just touch upon each one of those, just briefly.

On the regulation side, which was led by Ilisa Bernstein from the FDA, who I believe is here today, there was a lot of work done to try to help countries where their regulatory protocols were not as well structured, and to help control some of these issues of counterfeit medicines, and working with those teams to put out documents and to work on this area.

From that, there was also work between the regulatory agencies and other -- regulatory team and other teams. At the legislative level, there was a discussion about putting forth a concept or a paper and also a model law -- and I don't like to use that word lightly, because I don't want to say that there was an actual law put forth -- but something which would be able to be brought back to individual countries, to the different member states, to say, this is a document which you could work from within your legal systems to make the issue of a -- someone who has either manufactured a counterfeit drug or has been within that chain of counterfeit medicine, basically charged with -- more than just an infringement on a patent right; something much more forceful. And if someone died as a result of it, is this sort of more of a homicide, murder, or something equivalent within their legal structure?

And then the next part was that you could have the laws written down, you can have the regulatory bodies there, but if there's no way to enforce it. So our feelings were that the enforcement part -- which was led by Aline Plancon, who's here and will speak later, which was an incredible team of actually looking at the world customs organizations, Interpol and other ways to try to tackle the issue of borders and sort of getting rid of some of the porous issues at the borders, and to try to also work with the legislative bodies and others to tackle that part.

And then the next part was the issue of technology, and that was led by Harvey Bale, who is from the at that time IFPMA, which is the International Federation of Pharmaceutical Manufacturers. And the thought there was there must be a way to use technologies that are out there to tackle this. And we recognized in many meetings that it has to be tailored to the country. So the concepts of using something like RFID, radio frequency identification, may work in the United States or in Europe or other countries where spending, you know, several thousand dollars would be effective, but that's not going to really solve this problem in countries where that's just an exorbitantly high price. So we realized we had to tailor, tailor to the individual countries.

As a matter of fact, at that meeting, we had a meeting in Prague, I had thrown out the idea of the concept of using cell phones text messaging to actually use a way to validate medical bottles through a randomized number system, and I put that out there at that point. And recently, in the last year, I've heard that that has now -- I'm pleased to say, is out there in Ghana and other parts of the world. So that is a -- an idea that, you know, was out there at that time or that we -- that I put out there, but others had said could be used and now has been working.

And the last part was communication. And the communication issue issue was, we can have all this in place, but if people don't know about the issues and the messages aren't getting out there, then it's not going to really be effective. And so that team was working on communications and basically sort of addressing and branding these issues.

And from that we generated about a hundred people working on this, from member states, and there are multiple meetings, and we're moving forward on this.

Now I recognize that the issue -- and you asked this before, because it was brought up -- that the WHO -- the issue of counterfeits and impact has had some criticism at the WHO and the World Health Assembly recently. But I do think that a lot of this is the issue of coupling the issue of counterfeit medicines and intellectual property rights. And I think that we really do need to recognize that these are two separate issues.

And there has been a lot of -- a political component to why these things are coupled. And I guess I would put on my lawyer's hat for a second and say that there's really -- you have to look at this from the concept of the legal phrase "mens rea," which is, is there a guilty mind on this? And so if someone's doing something with a guilty mind to move something forward in the supply chain of medicines, then that truly is something which we need to tackle and in a lot of ways with counterfeit as we move forward.

And lastly I just would say that if there is a generated effort and resources put forth to move this forward, I think that the entire concept could be pushed forward with those five areas, and we could tackle this problem effectively.

DENTZER: Okay. And you've given us a very nice additional list of issues that need to be transcendent.

So, Director Barbano, we'd like to hear your brief case study now of a particular issue that surfaced with respect to Brazil's interest in drug and food safety.

DIRCEU BARBANO: Good morning to all. I am going to ask Tim for his help, so that I may speak to you seamlessly.

I'd like to first of all thank Mr. Richard Haass, president of the council, as well as Laurie Garrett, senior fellow, for her invitation, as well as Daniel and Stacey (sp) and members of the staff for bringing us here.

I brought for this panel a case that is apparently simple, involving a fruit from the Amazon River in -- Amazon region in Brazil, a fruit called Acai.

I heard with attention to the debate in the previous panel.

I would like to say that it's -- it would not be very prudent of me to start discussion on this theme without first a few considerations about the larger theme of this event.

It is undeniable that we have a very major challenge ahead of us. The world is changing, and the economic conditions are changing very rapidly. More people consume products that are manufactured worldwide, and this reality is irreversible. We will increasingly consume products that are manufactured elsewhere. On the one hand, it may be a problem; but on the other hand, it may see -- may be seen as a solution, as countries develop and produce other products.

We need to take on the perspective of health -- caring for health, preserving life, and putting health and life above all else. Brazil has recently taken the decision to become a more developed country, a more socially just and more economically just country. And that means that we do not want industries that produce goods that put people's lives at risk. We expect that our agricultural resources produce products that are of quality for the Brazilian consumers and for exports to other countries. We expect our pharmaceutical industries to produce medications that can be consumed, that are of quality, and that can resolve health issues for the Brazilian people, and to preserve life and to treat the Brazilian national as we would treat any other person from any other country.

Therefore, this discussion about falsified products and substandard products is of great interest to the Brazilian government. But we must understand that the risks in the consumption of medications and food do not lie exclusively in these products. There are risks of different nature.

The lack of food is a risk. And the lack of access to medication is also a risk.

And there are risks inherent in the consumption of products from anywhere in the world. Recently we had a problem with a substance called imiglucerase, which is manufactured by a company that is known worldwide, called Genzyme. The Brazilian government is a large consumer of this product. And the contamination problem in the facilities, in the equipment used to produce this substance, made it unavailable to the Brazilian people.

So we are speaking about topics of a global nature. And our challenge is to identify ways to work the problem as a global issue.

DENTZER: And that is exactly the topic that we want to move to, if you would.

BARBANO: And to that effect, this incident involving acai is very interesting. In 2007 -- in 2007, a contamination was identified related to the Chagas disease through the consumption of this fruit. We in the Amazon River were -- region, we identified 123 people who had the Chagas disease and no history of having been bitten by the bug. And we further identified that these cases were related to the ingestion, the consumption of the fruit, which was a new way of transmission.

In 2007, this fruit was largely consumed in Brazil, and it was already being exported to other countries. There was a large effort undertaken by the Brazilian authorities through ANVISA at the federal level and the secretariats of health in the state and local levels in order to identify, track and find a solution for the problem. And we also had the help of Brazilian universities that are specialized in the study of tropical diseases.

And we discovered that for the transmission of the disease was -- occurred through the ingestion of the raw fruit. And based on that, we developed a large effort to train the people who are responsible for harvesting and storing the product.

So after this process was undertaken, no other case has been identified. It involved changes in the process of harvesting, storing and processing the fruit.

This case is very interesting because it shows that in many instances, global efforts will be insufficient. Because these are localized products, it involves workers who work on a seasonal level. And that certainly occurs on a global level in many areas that produces food and even medications for global consumption. And the Brazilian government is very willing to find a solution for these problems and to identify a way for the sanitary vigilance agencies to expand their activities --

DENTZER: All right. I just have to seize on this because you've just laid on the table an extremely interesting point here, which is that even though we've been talking about global food and drug safety, all of this begins and to a large -- to some degree, it should end at the local level. Unless individual countries are as expert as Brazil has shown itself to be in seizing the problem, we are going to continue to have these disasters occur.

So let's go back to some of the issues that have now been put on the table, it's the capacity of local authorities to have the ample science to quickly detect issues. There has to be in place regulatory capacity in order for them to do that. There may, indeed, need to be comparability of legislative authority in individual countries, hence, the need potentially for model legislation. There also has to be cooperation across borders, obviously, among these agencies, not just the regulatory agencies, but also the police authorities as well. And technology and communication also could play a very important role.

Howard, you mentioned the possibility of radio frequency identification or also the more low-tech cell phone approach. And then communication -- and this point I want to stay on because we haven't talked yet about the role of public outrage and public demand of improvement of local authorities.

I was struck in the background that Laurie (sp) and her colleagues prepared that the CDC estimates in 2009, there were 3,000 deaths in the United States from contaminated food and drinks alone. Not to put too fine a point on that, but that's equivalent to the World Trade Center bombings as a disaster in terms of fatalities.

So where is the public outrage? And that can serve as a force to push more countries along?

Peggy?

HAMBURG: Well, I think that public engagement is absolutely essential.

And I think that it speaks to the fact that, certainly, in our country and I think in many countries across the world, that at the end of the day, whatever your political stripe, whatever your views about government overall, there are some key functions of government that people have enormous reliance on. They want to be able to trust and have confidence that their food and water supply will be safe.

They want to know that the drugs that they are taking and giving their family are safe as well. And I think for the most part in the United States, people assume that to be true. I don't know as much about attitudes in other countries, but, you know, it's something where people don't think about it until there's a problem. That's always been the challenge of public health that until there's a problem, people take it for granted.

But I think we saw with the Food Safety Modernization Act, actually, enormous mobilization of consumer groups and advocates with industry and with other critical stakeholders to say we have an opportunity to do better. And while the U.S. food supply, you know is extremely safe, that 3,000 deaths a year is too many, manyfold preventable hospitalizations and, of course, huge preventable costs to industry as well. And so there was this galvanization that led to action, which will make a difference.

But one reason why I was very excited to have this forum today is that I think people have no idea in this country and around the world about the vulnerability of things that we count on every day, food, drugs, medical devices and other related products. And that we have a system that has big gaps in our protective mechanisms and that it's a growing problem, and that, in fact, it is a problem that goes beyond what any one nation can do alone no matter how well resourced, no matter how dedicated.

It is a problem that by its very nature requires a global alliance. In my remarks this morning, I said I think the time has come that we really need to create and formalize a global alliance of regulators that are committed to solving these problems together, to sharing information in new ways, sharing best practices in new ways, even sharing the workload in new ways, and importantly, working with industry and other stakeholders because it is a shared responsibility that goes beyond government as well. But I think that in all these efforts, that notion of shared responsibility and the critical central role of the consumer, because at the end of the day, it's all about serving them and protecting and promoting their health and well being.

DENTZER: So on the possibility that regulatory authorities and individual countries will not all leap to the fore to take up your challenge, could we conceive of a global citizen Facebook revolution to enlighten people throughout the world about the need for these issues, Howard?

ZUCKER: I think that would be a great way to move forward in using any technologies that are out there to get the message out. I think that we should look at the Internet and the possibilities like that, although many of the individuals who are affected by this are in regions of the world where Internet capabilities aren't there, which goes back to the issues of cell phones and what kind of more low-tech -- more simple technologies would be available.

But I think it's also an issue as the commissioner mentioned is the need to get this message communicated and almost create a grassroots effort to make people aware of the problems that are there.

DENTZER: Text for safe food, for example, something like that.

Director Barbano, to bring you into this conversation again. What was -- in Brazil, was there resistance to the various food processors or others to you as a regulatory agency wading into this? And if so, how did you overcome that?

BARBANO: There is always some conflict of interest when we speak about sanitary vigilance regulation. And certainly these conflicts exist in Brazil, as they do in the U.S. and Europe.

It's important in this global effort what the degree of autonomy these institutions have in their own countries. In Brazil, when we created Anvisa, there was a concern to protect Anvisa from these kind of pressures. For example, we can mention as an example the use of agricultural protection agents. So when Anvisa establishes a limit on the use of these substances, there is a conflict with the producers and the farmers. But Brazil has a legal system that is consistent and supports the agencies' decisions in this regard.

DENTZER: All right. We're now going to open this up to questions and discussions from those of you in the audience. And it would be very helpful if you'd raise your hands, obviously, and identify yourselves by name and affiliation and a microphone will circulate to you.

Let's start with a hand right up there. Terrific. Thank you.

QUESTIONER: Hi, I'm Jean Halloran from Consumers Union and I also work with Consumers International.

I think it's very important not to be naive about the potential for a grassroots groundswell for food safety. Consumers all over the world do care, but we just saw the case in China where one of the parents of a melamine injured child was organizing other parents and was thrown in jail.

So there are limitations, but particularly in some of the countries we're most concerned about for grassroots activism.

I think we also need to look at and I wonder if any of the panelists can comment on our trade policy, because we established trade agreements as if all other countries in the world share our values and share our regulatory systems and commitments to them. And then when we start getting substandard products in because they have maybe even laws on the books that they don't enforce, you know, it's like, oh, my goodness, what do we do; you know, we treat it as if it's a surprise.

And I wonder if we can begin factoring into our trade agreements provisions that allow us to treat other countries in terms of the reality of their safety system.

DENTZER: All right, which gets us into an arena of trade policy, and I don't know that we have any experts on trade policy on the panel. But Peggy, do you want to take a crack at --

HAMBURG: Well, you know, I certainly don't pretend to be a trade policy expert, but what I hopefully am is a public health expert. And I think that that is the principle we need to organize our actions around; and we need to make sure that citizens of any nation, rich or poor, can have access to adequate food supplies and quality food supplies; and that, you know, there's a lot more that can and should be done; and that as we think about how to respond to a globalized world in a way that helps protect our own nation -- and that is my mandate as FDA commissioner, is to promote and protect the health of the American people -- I think it's critically important that I recognize and step up to the plate; that if I am to do that job well, it also means that I need to in fact care and invest and advocate for the quality of those commodities in other nations; and that at the end of the day, we need to try to approach ways, not to make every country identical in how they regulate these products, not to assume that every country, large and small, is going to have systems that look just like the U.S. FDA or other food and drug oversight entities from other countries, but that there will be some basic principles, there will be sharing of best practices, there will be efforts to proactively help build capacity through technical assistance and information-sharing; and that we will work in ways that are national, regional and global to really ensure that there's a minimum threshold of standards for food products around the world.

And I think that is, you know, the goal that I bring to this.

DENTZER: Well, how much contact do you have with the U.S. Trade Representative's office or the customs folks in terms of enforcing some of these food safety, or, for that matter, drug safety issues?

HAMBURG: Well, I would have to say that I don't think at present that there is enough conversation, communication and mutual understanding. And I think that we need as the U.S. Food and Drug Administration to, in fact, sit down more frequently with our counterparts. And it's something that I've engaged in.

I think the danger in not having this conversation is that, in fact, decisions get made on the basis of trade and commerce that may not, in fact, factor in critical aspects of public health. And so I think it's very, very important that we make sure that the public health issues are fully understood and aired as many of these broader trade debates go forward.

DENTZER: And I don't suppose we have any reason to believe that other countries do this markedly different, that there's more discussion among the trade authorities in other countries or is there?

HAMBURG: You know, my sense is that for many years there have been sort of parallel tracks and that, in fact, the public health issues have not been as central to the discussions as they need to be. We need to make sure that things that really matter for health, well being, and, in fact, safety and security more broadly are integrated into these discussions and ultimately into our policies.

DENTZER: Okay. That's terrific. Let's take a question over here, please.

QUESTIONER: Hi. Erik Olson with the Pew Charitable Trusts.

I had a question. One of the biggest policy challenges has been addressed a couple of times, but we haven't really heard an answer. FDA now, as I understand it, is inspecting about 1 percent of our imports, so 99 percent of the imported foods are not inspected.

We've heard it's going to cost $1.4 billion for FDA just to implement the new food safety law over the next five years. Assuming that all the budget cuts that everyone is talking about may hit FDA and other agency -- food safety agencies, what would the role be potentially for fees on the industry to help pay for this implementation? We know in PDUFA for drugs, the drug industry pays fees to pay for their regulatory system in part. And I believe that the Obama administration supported the House legislation that add fees for food safety implementation.

Is that something that really might be part of the solution here, not just in the United States, but potentially more globally, to make sure that this new web of international trade and food, and frankly, in drugs, really -- that we get a handle on it, that regulatory authorities can inspect more than 1 percent of the imports and perhaps do some of the overseas inspections that are required in the new legislation.

HAMBURG: I think there really are two overlapping issues here, and we don't want to completely put them together, one is the question of how do we implement the food safety bill, which is enormously important and does begin to get at some of the global food safety issues that are so critically important. And there's no question that the law puts forward a number of very prescriptive actions for us to take, all of which are very important and much needed, including enhancing inspectional activities. And yet it's an unfunded mandate as we like to say. And it does raise serious issues for us.

As was mentioned in the first panel, industry cares enormously, in fact, about achieving the goals of this new legislation and strengthening food safety, and importantly, implementing the preventive focus that's part of the Food Safety Modernization Act to prevent problems from happening in the first place rather than trying to scramble after them once they've occurred.

And so I do think that industry is willing to step up to the plate in terms of resources and partnership to take more responsibility and accountability.

For their contribution to ensuring the safety of the global and domestic supply chain. And so we really need to work on that. And we really need to make sure that the goal of the Food Safety Modernization Act can be realized in our implementation.

I think looking more broadly at the circumstances of globalization and what it means for medical product and food safety, we have to recognize this isn't a problem that our nation or any other nation can inspect its way out of. It really is a problem that requires a fundamental shift in how we think about the problem and how we work together as two partners across nations and governments, as well as across sectors.

Because of the complexity of the global supply chain and the magnitude of the problem, you know, really means that we have to to, you know, work together in completely new ways, sharing information, sharing best practices, sharing workload as I said before we need really different systems that break down some of the traditional stovepipes of our different institutions to think and act in multinational coordinated ways. And I think that's a huge challenge, but it's also, I think, the only way we will achieve success and there is a huge opportunity to do things in new and different ways because the challenges before us simply demand it.

DENTZER: Peggy, you used a phrase in your opening remarks that that there are 20 million different lines -- did I get that right? -- of -- that's all products imported into the United States that are under FDA's jurisdiction reinforcing your point that we can't inspect our way out of this because there's no way we're going to inspect 20 million lines. And that's lines, so I assume it's multiple products in each of those lines.

HAMBURG: You know, we can do a better job with inspection and we need to. It's not that inspection doesn't have a role; it has a huge role, both at the borders and in the different countries where products are being made. But we have to do much more than that and it involves taking an approach that both is much more collaborative and also much more risk-based -- you know, we really need to focus on the things that will make the most difference.

And assessing and monitoring risk is a dynamic, ongoing process, but again, it can only be done effectively if we're really sharing information across governments and across sectors to understand the range of vulnerabilities, how those vulnerabilities may be changing because some products may be vulnerable because of bad actors that become identified in one country or another. That information gets shared and then we can all act on that information.

Products may become more vulnerable because of environmental conditions that may actually change the risk profile and sharing information on that. And certain products are more vulnerable by their very nature. But the more we can really take a risk-based approach, the more we can really take a preventive approach and the more we can really take a approach of true collaboration, the more progress we'll make towards our goals.

DENTZER: Great. All right. Let's go to a question right there in the middle, please.

QUESTIONER: Dan Spiegel, Covington & Burling. Turning to the World Health Organization for a moment, the program that Dr. Zucker put together, the impact program I think we ought to say is no longer the program that he originally designed, which was originally supported by consensus. That consensus has -- at the member state level has broken down. And my question for Director Barbano is, could you inform us, do you know why Brazilian diplomats in Geneva have worked so hard against a WHO role that would strengthen its enormative standard- setting and its operational capacity to work in innovative ways to deal with drug and food safety?

BARBANO: This issue is very much related to what Dr. Heymann alluded to in the previous panel. The Brazilian position in this regard is very clear.

Not to assume that every country large and small is going to have systems that look just like the U.S. FDA or other food and drug oversight entities from other countries. But that there will be some basic principles, there will be sharing of best practices. There will be efforts to proactively help build capacity through technical assistance and information-sharing. And that we will work in ways that are national, regional and global to really ensure that there's a minimum threshold of standards for food products around the world. And I think that is, you know, the goal that I bring to this.

DENTZER: Well, how much contact do you have with the U.S. Trade Representative's office or the customs folks in terms of enforcing some of these food safety, or, for that matter, drug safety issues?

HAMBURG: Well, I would have to say that I don't think at present that there is enough conversation, communication and mutual understanding. And I think that we need as the U.S. Food and Drug Administration to, in fact, sit down more frequently with our counterparts. And it's something that I've engaged in.

I think the danger in not having this conversation is that, in fact, decisions get made on the basis of trade and commerce that may not, in fact, factor in critical aspects of public health. And so I think it's very, very important that we make sure that the public health issues are fully understood and aired as many of these broader trade debates go forward.

DENTZER: And I don't suppose we have any reason to believe that other countries do this markedly different, that there's more discussion among the trade authorities in other countries or is there?

HAMBURG: You know, my sense is that for many years there have been sort of parallel tracks and that, in fact, the public health issues have not been as central to the discussions as they need to be. We need to make sure that things that really matter for health, well being, and, in fact, safety and security more broadly are integrated into these discussions and ultimately into our policies.

DENTZER: Okay. That's terrific. Let's take a question over here, please.

QUESTIONER: Hi. Erik Olson with the Pew Charitable Trusts.

I had a question. One of the biggest policy challenges has been addressed a couple of times, but we haven't really heard an answer. FDA now, as I understand it, is inspecting about 1 percent of our imports, so 99 percent of the imported foods are not inspected.

We've heard it's going to cost $1.4 billion for FDA just to implement the new food safety law over the next five years. Assuming that all the budget cuts that everyone is talking about may hit FDA and other agency -- food safety agencies, what would the role be potentially for fees on the industry to help pay for this implementation? We know in PDUFA for drugs, the drug industry pays fees to pay for their regulatory system in part. And I believe that the Obama administration supported the House legislation that add fees for food safety implementation.

Is that something that really might be part of the solution here, not just in the United States, but potentially more globally, to make sure that this new web of international trade and food, and frankly, in drugs, really -- that we get a handle on it, that regulatory authorities can inspect more than 1 percent of the imports and perhaps do some of the overseas inspections that are required in the new legislation.

HAMBURG: I think there really are two overlapping issues here, and we don't want to completely put them together, one is the question of how do we implement the food safety bill, which is enormously important and does begin to get at some of the global food safety issues that are so critically important. And there's no question that the law puts forward a number of very prescriptive actions for us to take, all of which are very important and much needed, including enhancing inspectional activities. And yet it's an unfunded mandate as we like to say. And it does raise serious issues for us.

As was mentioned in the first panel, industry cares enormously, in fact, about achieving the goals of this new legislation and strengthening food safety, and importantly, implementing the preventive focus that's part of the Food Safety Modernization Act to prevent problems from happening in the first place rather than trying to scramble after them once they've occurred.

And so I do think that industry is willing to step up to the plate in terms of resources and partnership to take more responsibility and accountability.

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ZUCKER: Well, this is where I think it comes down to the public and all those who work in this area to say we need to separate these out to a certain extent. For example, there is areas of overlap in the sense that there are issues of patents on medicine. But I think the more we merge these together -- and we have to remember, from a historical perspective, while this whole issue of counterfeit medicines was being addressed to the World Health Organization, there was also the whole issue of intellectual property rights which was moving forward. There was issues of vaccines in Indonesia and some of the issues with the flu.

And so all these things were sort of in the mix. And I think it's very important to tease these out. As the clinician, sometimes you sort of have to tease out on medical problem from the other. And you can look at them together, but you have to sort of separate them out at times and address them separately. And I think that until we do that a little bit, we're going to run into some problems.

DENTZER: And the question will be whether 20 countries could get together and do precisely that.

Let's take a question all the way in the back. I've been neglecting the back of the room.

QUESTIONER: Hello, everyone, my name is Ashifi Gogo. I'm the CEO of Sproxil. We provide SMS verification services with (NASDAQ ?) in Nigeria.

I wanted to provide an alternative view on the first question, which is public advocacy of food safety concerns based on my experience in Nigeria. A consumer called in indicating that there was a mixture of genuine and fake medication, and information was passed on to the -- (inaudible) -- was able to take action and find the counterfeiter in the act selling fake drugs to consumers, using SMS technology.

So I'm wondering, is sort of a hotline police tipoff style system instead of maybe a public NGO might be a way to engage consumers who are in pharmacies multiple times a week to essentially report incidents of suspicious activity in pharmacies to enhance the safety for the public?

DENTZER: Well, anything like that?

HAMBURG: Well, I'll start and others will, I'm sure, want to elaborate. Reports from consumers about the quality of their products and adverse reactions, very, very important to the work that we do at FDA. And we rely on getting that kind of information and encourage it.

One of the challenges with these substandard drugs is that consumers may not recognize that they're not getting what they think they're getting, and that's one of the very serious dangers is that you may think you're getting a drug that's treating your condition. But if you are doing poorly, you may not realize it's because the drug isn't adequate; you may think your disease is just progressing or think maybe you're on the wrong medicine. But sometimes you don't know, and that's one of the dangers with malaria medications -- what we're seeing is, you know, not only are populations being treated with drugs that are inactive, but also contributing to the drug problem of drug resistance because they may be being partially treated with a substandard drug. And then, in fact, you're creating a problem with the organism, which then means that the actual quality drugs no longer treat it as well because of resistance.

So they're very complex problems that can unfold if you think about the challenge of whether a person is taking the drugs that they're thinking that they're taking. When it actually has a toxic component, it makes it a lot easier.

Someone commented that when there's a problem that's acute, the red flags go up and you can usually respond. But when it's a chronic exposure that can be damaging or an inadequate drug, it's much harder for the consumer to always be aware, but any reports are valuable. Also, reports of what appear to be inappropriate practices in pharmacies are also very, very valuable. And I think that, you know, if we're going to be successful, we need to galvanize as much of that kind of consumer information as we can and match that to other types of information so that we can get the clearest picture that we possibly can so that actions that are meaningful can be taken.

ZUCKER: One of the other things that WHO had started back in '07 was the concept of having some way to track and having -- basically, through the computers there is a way you can go onto a map, find out, file reports in, tap on that country, tap on that region and they have a lot of information coming back. Larry Reggie (sp) who was incredibly instrumental, a lot of the work on this, was trying to push that forward at that point. And I don't know where it is at this point, but that was one one of the concepts of trying to do just what was mentioned -- you mentioned to track.

DENTZER: Is that the equivalent of a global sort of adverse- event reporting sharing capacity?

ZUCKER: That was -- that was -- it was sort of -- the concept came from that kind of system, because that was being done for issues of flu at the time.

DENTZER: Perhaps somebody in the audience knows the status of that.

Dr. Barbano?

BARBANO: Susan, in Brazil in 2009, the Brazilian Congress adopted a law that establishes a system to control -- to track medications. And we are in the final stages of identifying the technology that will be used. And that technology will allow the consumer to verify the authenticity of the medication at the pharmacy. Many other countries in the world already use that technology. The FDA has expressed its interest in familiarizing itself with the technology, and we already have two teams exchanging information.

DENTZER: And what is the technology?

BARBANO: It's a technology that uses a bilateral code based on data metrics and (a seal ?). And that will allow a database to be established, which will allow for tracking the medication and some device to verify the authenticity. And this has the full support of the pharmaceutical industries in Brazil, both the national industries and foreign.

I'd like to mention something that might be of interest to this event. The OAS has created a network. Brazil joined the network at the end of last year. It is called the Safe Consumption Network in Health. This is the first step to create the network that will have the capability to centralize alerts and make them available in a portal. I believe that the OAS will have this portal functioning within three months in English, Spanish and Portuguese.

HAMBURG: And that's under the auspices of the Organization of American States. Is FDA a party to that? Do we know?

BARBANO: Yes.

HAMBURG: I -- I am glad to hear that. I have to confess I don't know the details. But we try to get our fingers into any international or regional activity that we can, because it really is, I think, so important to us.

DENTZER: So the point was made earlier that many countries will not have the capacity to use some of these technological solutions because of resource constraints. But here is Brazil, a middle-income country, putting in place what sounds like -- is it -- is it a bar-coding system that was put in place? So it's not out of the question that these technologies could become more useful in these countries. So perhaps we'll have some conversation about addressing those capacities.

BARBANO: After we began conducting electronic elections in Brazil, the world began to believe that we have some technological -- (laughter).

DENTZER: Okay, well -- and then -- (laughter) -- and then you can export the technology back to the United States.

(Laughter.) Okay.

Question over here, please.

QUESTIONER: Hello. My name is James Tunkey. I'm an entrepreneur as well as a director of the International Council for the Life Sciences. I just first want to congratulate the council and Laurie Garrett for putting this conversation together.

My question is for the panel. It doesn't seem to me that we've moved from a consideration of intellectual property rights and the private profit motive to the reputation risk really that is posed to government organization in the case of failure of food safety.

And I think that there's some real contrasting styles of approach to governments, both in governance of private enterprise, as we see here in the United States primarily; and governments in Brazil, which continues to really have a much more state-centric approach to drug development and production.

And so if you could just speak a little bit about the policy challenges of moving from the view of one that's focused on intellectual property rights protection by private industry to one that's focused on reputation risk of food failure safeties (sic), I'd appreciate it. Thank you.

DENTZER: Well, I'm unclear as to whether your question pertains to the drug safety or the food safety issue. So -- both? Okay.

So -- well, let's have at it.

HAMBURG: I mean, at the end of the day, I think that agencies like the Food and Drug Administration and the industries that we regulate do have common purpose, in that trust and confidence in the work that we do and the products in question is the ultimate goal, and that -- you know, I certainly think that if you look at history, you can see that industry, in fact, does better when there is a strong, well-functioning regulatory authority. And I think that as we were working on the Food Safety Modernization Act, we saw industry's real engagement and investment in systems and a legal regulatory framework that would support their ability to maintain trust and confidence in their -- in their brands.

So I think it's a hugely galvanizing principle. I don't know exactly how you frame the issues of intellectual property versus the reputational. I think often they intersect. If you have a brand-name product, you want to keep that brand.

But I think that, you know, stepping back and just looking at the importance of confidence in the products -- you know, whether they're generic drugs or brand-name drugs; whether they're food manufactured by a big multinational company or at a more, you know, local community level -- that still is, I think, an organizing principle. And it's where a strong but modern and, I think, you know, clear regulatory approach supports the ability of industry to achieve their goal, and in fact, our interests do align.

I don't know if that answers your question or not, but --

DENTZER: It sounds like the Chinese authorities decided to get everybody's attention by putting a few people to death. Presumably, we will come up with a more collaborative approach -- (laughter) -- as Peggy mentioned earlier.

We are out of time for this panel -- sad to say -- but I think we've worked our way through a series of the issues that we've already discussed, whether it's the lack of regulatory capacity, whether it's differences in legislation, whether it's incapacity in terms of technology.

But I think fundamentally you also heard under the surface of the comments today, fundamental other lacking obstacles that we'll have to get over in order to do more in this area. One is will; it's just plain will, countries having the will to do this. It's engendering a greater awareness among consumers in particular. And essentially, we will also eventually have to address the lack of resources being devoted to this capacity among all these countries.

So join me now in thanking this panel for a terrific discussion. (Applause.)

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